Efficacy and safety of Levamisole treatment in clinical presentations of non-hospitalized patients with COVID-19: a double-blind, randomized, controlled trial

Amirreza Roostaei Firozabad,Fatemeh Saghafi,Zohreh Akhoundi Meybodi,Mohsen Gholinataj Jelodar,Seyed Ruhollah Mousavinasab,Iman Karimzadeh,Solomon Habtemariam,Adeleh Sahebnasagh

doi:10.1186/s12879-021-05983-2

Abstract

BackgroundLevamisole has shown clinical benefits in the management of COVID-19 via its immunomodulatory effect. However, the exact role of Levamisole effect in clinical status of COVID-19 patients is unknown. We aimed to evaluate the efficacy of Levamisole on clinical status of patients with COVID-19 during their course of the disease.MethodsThis prospective, double-blind, randomized controlled clinical trial was performed in adult patients with mild to moderate COVID-19 (room-air oxygen saturation > 94%) from late April 2020 to mid-August 2020. Patients were randomly assigned to receive a 3-day course of Levamisole or placebo in combination with routine standard of care.ResultsWith 25 patients in each arm, 50 patients with COVID-19 were enrolled in the study. Most of the study participants were men (60%). On days 3 and 14, patients in Levamisole group had significantly better cough status distribution when compared to the placebo group (P-value = 0.034 and 0.005, respectively). Moreover, there was significant differences between the two groups in dyspnea at follow-up intervals of 7 (P-value = 0.015) and 14 (P-value = 0.010) days after receiving the interventions. However, no significant difference in fever status was observed on days 1, 3, 7, and 14 in both groups (P-value > 0.05).ConclusionThe results of the current study suggest that Levamisole may improve most of clinical status of patients with COVID-19. The patients receiving Levamisole had significantly better chance of clinical status including cough and dyspnea on day 14 when compared to the placebo. However, the effect-size of this finding has uncertain clinical importance.Trial registrationThe trial was registered as IRCT20190810044500N7 (19/09/2020).

Highlights

Levamisole has shown clinical benefits in the management of COVID-19 via its immunomodulatory effect
Considering the pathophysiology of COVID-19 and the immunomodulatory properties of Levamisole, we conducted this double-blind, randomized controlled trial to evaluate the efficacy and safety of Levamisole when compared to the routine standard of care in non-hospitalized patients with mild to moderate COVID-19. This prospective, double-blind, randomized controlled clinical trial was performed in adult patients aged between 18 to 60 year old with mild to moderate COVID19 who referred to the infection clinic of Shahid Sadoughi Hospital, Yazd, Iran
There were no significant differences in demographic characteristics between groups

Summary

Introduction

Levamisole has shown clinical benefits in the management of COVID-19 via its immunomodulatory effect. The exact role of Levamisole effect in clinical status of COVID-19 patients is unknown. We aimed to evaluate the efficacy of Levamisole on clinical status of patients with COVID-19 during their course of the disease. In late December 2019, a novel human coronavirus, Severe Acute Respiratory Syndrome Coronavirus 2 (SARSCoV-2 or COVID-19), was identified as the cause of a series of pneumonia cases in Wuhan, Hubei Province in China [1,2,3]. The binding of the SARSCoV-2 to the ACE-2 receptors triggers an inflammation cascade in the lower respiratory tract and causes a systemic inflammatory state. Infection of human cells by SARS-CoV-2 results in inflammatory cascade by virus-infected antigen-presenting cells (APCs). Some therapeutic agents are used offlabel, alone or in combination [13]

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